ABOUT REBLOZYL:
FAQs

What is MDS-associated anemia?

Myelodysplastic syndromes (MDS) is a blood cancer in which the bone marrow fails to make enough healthy red blood cells (RBCs), white blood cells (WBCs), or platelets (PLTs).^1,2

Low RBC count, as measured by hemoglobin (Hgb), is a key clinical signal in MDS-associated anemia.  Anemia is the most common type of low blood cell count in patients with lower-risk myelodysplastic syndrome (LR-MDS).^1,3

What is REBLOZYL (luspatercept-aamt)?

REBLOZYL^® (luspatercept-aamt) is indicated for the treatment of anemia without previous erythropoiesis-stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes who may require regular red blood cell transfusions.⁴

REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.⁴

Learn more about which of your patients may be appropriate for REBLOZYL.

How does REBLOZYL work?

Imbalanced erythropoiesis leads to a lack of mature red blood cells and triggers overproduction of erythropoietin. REBLOZYL restores erythropoiesis by increasing the number and improving the quality of mature RBCs as observed in preclinical studies.^5-7*

In preclinical models, REBLOZYL improved^5-7:

• Hgb levels
• RBC morphology
• Other hematology parameters^† associated with ineffective erythropoiesis

*REBLOZYL binds several TGF-β superfamily ligands, thereby diminishing Smad 2/3 signaling and increasing the number of mature RBCs.^6,7
†Other hematology parameters include reducing oxidative stress in erythrocytes, reducing accumulation of α-globin aggregates in erythrocyte membranes, and improving RBC lifespan.⁷

See how REBLOZYL works to restore balance in erythropoiesis.

What is the COMMANDS clinical trial?

COMMANDS is a head-to-head study between REBLOZYL and epoetin alfa that assessed outcomes including hemoglobin improvement and red blood cell transfusion independence (RBC-TI) in adult patients with anemia due to LR-MDS who require RBC transfusions.⁴

Primary endpoint: 58.5% of patients taking REBLOZYL achieved the primary composite endpoint of ≥12 week red blood cell transfusion independence (TI) and Hgb increase ≥1.5 g/dL (n=86/147; 95% CI: 50.1, 66.6) vs 31.2% of patients taking epoetin alfa (EA) (n=48/154; 95% Cl: 24.0, 39.1).⁴

The most common (>10%) all-grade adverse reactions included diarrhea, fatigue, hypertension, edema peripheral, nausea, and dyspnea.⁴

Review the COMMANDS trial patient population and study design.

The primary endpoint was a composite of RBC-TI for ≥12 weeks with a concurrent mean Hgb increase ≥1.5 g/dL during Weeks 1–24.⁴

When should treatment initiation be considered for first-line LR-MDS anemia?

Treatment can be considered when Hgb is <10 g/dL. Studies in LR-MDS anemia have shown that Hgb <10 g/dL is associated with potentially worse quality of life (QoL), shorter overall survival (OS), and increasing RBC (red blood cell) transfusion burden. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) recommend a target Hgb range of 10 to 12 g/dL for patients with LR-MDS anemia.^8-12*

Quality of Life^8,9:

Oliva et al 2012: In 148 newly diagnosed LR-MDS patients, decreases in Hgb (measured by EQ-5D, LASA, and QOL-E) were linked to worse QoL.

Stauder et al 2018: In an observational, prospective study of 1,690 MDS patients from the EUMDS registry, Hgb <10 g/dL (EQ-5D) was associated with worse QoL.

Overall Survival¹⁰:

Greenberg et al 2012: In 7,012 untreated MDS patients (77% LR-MDS), lower Hgb was associated with worse survival. Median survival: <8 g/dL=2.0 yrs; 8-<10 g/dL=2.9 yrs; ≥10 g/dL=5.5 yrs.

*For patients with symptomatic anemia. Not to exceed 12 g/dL.¹²

Explore how Hgb levels can impact your patients’ anemia.

What is the hemoglobin response data for patients on REBLOZYL?

In the COMMANDS clinical trial, higher baseline hemoglobin levels were associated with higher response rates to REBLOZYL.* In patients with baseline Hgb ≥8 to <10 g/dL, 65.3% responded to REBLOZYL compared with 41.1% with epoetin alfa.^† In patients with baseline hemoglobin (Hgb) <8 g/dL, response rates were 57.3% with REBLOZYL vs 30.6% with epoetin alfa.^13‡

Analysis limitations¹⁴:

• These analyses should not be interpreted to determine treatment differences between arms in these subgroups due to limited sample size, lack of statistical hypothesis testing, and increased probability of a false-positive finding.
• Subgroup analyses were performed for the primary and key secondary efficacy endpoints. Formal hypothesis testing was not performed in the subgroup analysis.

*Response defined as ≥1.5 g/dL increase in Hgb and at least 12 weeks of TI.¹³

^†REBLOZYL: n=47/72; Epoetin alfa: n=30/73.¹³

^‡REBLOZYL: n=63/110; Epoetin alfa: n=33/108.¹³

See the relationship between Hgb levels and REBLOZYL response rates.

Which patients are appropriate candidates for first-line treatment with REBLOZYL?

REBLOZYL is approved for first-line use in patients with lower-risk myelodysplastic syndrome (LR-MDS)–associated anemia who may require regular red blood cell (RBC) transfusions.⁴

REBLOZYL was studied head-to-head in COMMANDS, a registrational trial comparing REBLOZYL with epoetin alfa for first-line use in erythropoiesis-stimulating agent (ESA)-naive LR-MDS anemia patients who required regular RBC transfusions.⁴

See what a potential candidate for REBLOZYL may look like.

Explore the COMMANDS efficacy data.

Are ring sideroblast (RS-) and erythropoietin (EPO) ≤200 U/L patients appropriate first-line candidates for REBLOZYL?

Yes, first-line RS- and EPO ≤200 U/L LR-MDS patients were included in the COMMANDS trial and are eligible for REBLOZYL.⁴

In the intention to treat population, patients receiving REBLOZYL demonstrated nearly 2x higher response rates vs epoetin alfa. 58.5% of patients receiving REBLOZYL achieved the primary endpoint (n=86/147; 95% CI: 50.1, 66.6) vs 31.2% of patients receiving epoetin alfa (n=48/154; 95% CI: 24.0, 39.1).⁴*

Responses were also seen across key subgroups, including RS- patients and those with EPO ≤200 U/L.⁴

In patients with EPO ≤200 U/L, 66% of patients receiving REBLOZYL (n=96/145) achieved red blood cell transfusion independence (RBC-TI) lasting ≥12 wks with a concurrent mean Hgb increase of ≥1.5 g/dL during Wks 1-24 vs 41% of patients receiving epoetin alfa (n=59/144).^15†

In patients who were RS-, 47% of patients receiving REBLOZYL (n=23/49) achieved RBC-TI lasting ≥12 wks with a concurrent mean Hgb increase of ≥1.5 g/dL during Wks 1-24 vs 50% of patients receiving epoetin alfa (n=25/50).^15†

*Common rate difference (95% CI): 26.6 (15.8, 37.4) P<0.0001.^4
†Data cutoff date: September 2023.¹⁵

What are the side effects of REBLOZYL?

Grade >3 (>2%) adverse reactions included hypertension and dyspnea.⁴

The most common (>10%) all-grade adverse reactions included diarrhea, fatigue, hypertension, peripheral edema, nausea, and dyspnea.⁴

How should REBLOZYL be dosed in first-line lower-risk myelodysplastic syndromes (LR-MDS)–associated anemia?

The recommended starting dosage of REBLOZYL is 1 mg/kg once every 3 weeks by subcutaneous injection for the treatment of first-line LR-MDS–associated anemia. Before each dose, monitor hemoglobin (Hgb), transfusion need, and tolerability.⁴

Dosage should be increased to maintain the patient’s hemoglobin concentrations within the target range of 10 g/dL to 12 g/dL or transfusion independence (TI), to a maximum of 1.75 mg/kg.⁴

Continuous Hgb monitoring and appropriate dose escalation is required to maintain clinical response from REBLOZYL. In the COMMANDS registrational trial, 65% of patients treated with REBLOZYL required the maximum dose of 1.75 mg/kg.^4,16

See full dosing recommendations in the full Prescribing Information or by clicking the button below.

How is REBLOZYL administered?

REBLOZYL is administered subcutaneously once every 3 weeks. REBLOZYL should be administered by a healthcare professional.⁴

Instructions for administering REBLOZYL⁴

Prior to injection, allow solution to reach room temperature for a more comfortable injection.

Step 1: Add Sterile Water for Injection, USP

• Calculate the exact total dosing volume of 50 mg/mL solution required for the patient

Step 2: Plan and prepare for injection

• Slowly withdraw the dosing volume of the REBLOZYL reconstituted solution from the single-dose vial(s) into a syringe
• Divide doses requiring larger reconstituted volumes (ie, >1.2 mL) into separate, similar-volume injections and inject into separate sites

Step 3: Administer subcutaneously

• Administer the injection subcutaneously into the upper arm, thigh, and/or abdomen
• If multiple injections are required, use a new syringe and needle for each subcutaneous injection

NOTE: Discard any unused portion. Do not pool unused portions from the vials. Do not administer more than 1 dose from a vial. Do not mix with other medications.

Not sure how to store REBLOZYL?

How is REBLOZYL reconstituted?

REBLOZYL should be reconstituted and administered by a healthcare professional.⁴

• REBLOZYL is administered subcutaneously and is available in 2 vial sizes (25 mg and 75 mg)
• Reconstitute REBLOZYL with Sterile Water for Injection, USP only

Instructions for reconstituting REBLOZYL⁴:

Step 1: Add Sterile Water for Injection, USP

Reconstitute with Sterile Water for Injection, USP using volumes described in the Reconstitution Volumes table with the stream directed onto the lyophilized powder. Allow to stand for 1 minute.

Step 2: Discard the needle and syringe used for reconstitution

The needle and syringe used for reconstitution should not be used for subcutaneous (SC) injections.

Step 3: Mix and wait

Gently swirl the vial in a circular motion for 30 seconds. Stop swirling and let the vial sit in an upright position for 30 seconds.

Step 4: Inspect

Inspect the vial for undissolved particles. If undissolved powder is observed, repeat step 3 until the powder is completely dissolved.

Step 5: Invert, mix, and wait

Invert the vial and gently swirl in an inverted position for 30 seconds. Bring the vial back to the upright position, and let it sit for 30 seconds.

Step 6: Repeat

Repeat step 5 seven more times to ensure complete reconstitution of material on the sides of the vial.

Step 7: Inspect

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. REBLOZYL is a colorless to slightly yellow, clear to slightly opalescent solution, which is free of foreign particulate matter. Do not use if undissolved product or foreign particulate matter is observed.

Step 8: If the reconstituted solution is not used immediately

• Store at room temperature at 20°C to 25°C (68°F to 77°F) in the original vial for up to 8 hours. Discard if not used within 8 hours of reconstitution
• Alternatively, store refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours in the original vial. Remove from refrigerated condition 15-30 minutes prior to injection to allow solution to reach room temperature for a more comfortable injection. Discard if not used within 24 hours of reconstitution
• Do not freeze the reconstituted solution

Please see the REBLOZYL reconstitution page to learn more.

What insurance coverage is available for REBLOZYL?

~90% of insured patients nationwide have coverage to label for REBLOZYL in first-line myelodysplastic syndromes (MDS)-related anemia treatment. Insurance coverage for REBLOZYL varies by payer.

BMS Access Support^® offers benefit investigation services to help HCP offices understand coverage, prior authorization (PA) requirements, and payer-specific criteria.

What Prior Authorization (PA) criteria are commonly required for REBLOZYL?

Common PA criteria may include documentation of the patient’s diagnosis, relevant laboratory and clinical parameters (such as hemoglobin level and RBC transfusion history), and risk classification, as well as any other information required to confirm that use aligns with the FDA‑approved indication.

Requirements vary across health plans, and some may request additional or different clinical details for initial approval.

See the access handbook for more information.

Looking for support for your patients?

BMS Access Support is dedicated to helping patients access their prescribed BMS medications.

Patient access support, reimbursement resources, and financial support options may be available through BMS Access Support

• Call a Patient Access Specialist at 1-800-861-0048 8 AM to 8 PM ET, Monday-Friday
• Visit www.BMSAccessSupport.com
• Schedule a meeting with a BMS Access and Reimbursement Manager on the BMS Access Support Website

What financial support services are available for my patients?

BMS Access Support^® can help identify financial assistance programs for eligible patients who have been prescribed BMS medications and who need help managing the cost of treatment. The appropriate program will depend on the patient’s coverage.

For more information, visit BMS Access Support or call 1-800-861-0048, 8 AM to 8 PM ET, Monday–Friday.

How do I enroll patients in BMS Access Support^®?

BMS Access Support^® offers both online and fax enrollment. Start here to conduct a benefits review, initiate assistance with prior authorizations and appeals, and request financial support program enrollment for eligible patients. Once the enrollment form has been submitted and a benefits review has been conducted, you will receive your patient’s summary of healthcare benefits.

For more information, visit BMS Access Support or call 1-800-861-0048, 8 AM to 8 PM ET, Monday–Friday.

Where can I find billing and reimbursement information for REBLOZYL?

BMS Access Support^® may help support patient access by conducting benefits reviews and offering prior authorization and appeals process assistance for enrolled patients. Additionally, you can access product-specific billing and diagnosis codes, reimbursement and coding guides, distribution information, and additional coverage support offerings. Additional eligibility criteria and terms may apply. Bristol Myers Squibb and its agents make no guarantee regarding reimbursement for any service or item.

For more information, visit BMS Access Support or call 1-800-861-0048, 8 AM to 8 PM ET, Monday–Friday.

View available coding and coverage information for REBLOZYL.

Are there charitable foundation resources available to help eligible patients with treatment costs?

BMS Access Support^® can help identify charitable foundation resources that may provide funding for eligible patients. Patients may be eligible for financial assistance from charitable foundations if they do not have prescription drug insurance, have insurance through a government healthcare program, or have a commercial plan but still need help. It is important to note that these foundations are independent from Bristol-Myers Squibb Company. Each foundation has its own eligibility criteria and evaluation process. Bristol Myers Squibb cannot guarantee that a patient will receive assistance.

For more information, visit BMS Access Support or call 1-800-861-0048, 8 AM to 8 PM ET, Monday–Friday.

What materials are available to assist with medication access and reimbursement?

BMS Access Support^® provides standard forms and documents, office assistance tools, helpful guides, and videos to support the patient journey.

For more information, visit BMS Access Support or call 1-800-861-0048, 8 AM to 8 PM ET, Monday–Friday.

How can I contact Bristol Myers Squibb for more information?

Find ways to connect with BMS on our Contact Us page.

What patient resources are available?

There are a variety of resources available to patients through the REBLOZYL patient website, including brochures and answers to frequently asked questions.

Are there support programs that exist for REBLOZYL?

Yes. Patients can sign up to get educational resources along their patient journey.

What online resources are available?

Patients are able to see how REBLOZYL is making a difference in the lives of many people by visiting the REBLOZYL patient website and hearing about their stories.

Are there patient advocacy groups for lower-risk myelodysplastic syndromes (LR-MDS)?

There are a variety of organizations that provide disease education, additional support, and expert opinions.